Spanish Melanoma Multidisciplinary Group (GEM): Long-term survivors treated with ipilimumab (IPI) in the expanded access programme (EAP).
e20007 Background: Advances in metastatic melanoma treatment have demonstrated improvement in survival. After 5 year follow-up of clinical trials with IPI, LTS have been reported. Current follow-up of patients treated within IPI EAP in Spain is 2 years. Methods: we performed a retrospective subgroup analysis of 138 treated patients (pts) within the IPI not randomized EAP (48% of the total EAP population). LTS were defined as pts with ≥ 12 months overall survival (OS). Pts were treated with IPI at 3 mg/kg q 3 w x 4. Data was registered using a socio-demographic and therapeutic questionnaire, collecting overall response (RR), survival (OS) and toxicity (T). Results: In our analysis of138 treated pts 39 were LTS (28.2%), 14 pts were alive at 12 months (M), 12 pts between 13-19 m and 7 pts 20-24m, for all this patients the follow up continues. Median age was: 56.5 (30-81). Gender: Male 48.7%. Stage: IVa 25.6%, IVb 17.9%, IVc 56.8%. Primary tumor site: skin 56.4%; accral 12.8%; mucosal 10.3%; ocular 10.3%; rest unknown. Metastases (mts): soft tissue 38.5%, lung 33.3%, visceral 28.2%. Median number of prior treatments: 1 (1-5), 20.5% received more than one chemotherapy (chx) line. 92.3% of total pts population have completed the induction schema (4 IPI doses). Response assessment: CR 15.4%; PR 38.5%; SD 33.3%; P 12.8%. Mean duration of response: 10.6m. Mean survival: 16.6m. 56.4% received thx after IPI, in those pts 41% received chx; 17.9% radiotherapy; 12.9% B-RAF inhibitor. 18 pts (46.2%) presented T: 12.8% Grades (G) 3-4 were reported; 23.1% G2; 7.7% G1. The most frequent T was cutaneous (17.9%). When compared with the overall EAP pts population LTS have less visceral disease, lower median LDH, more objective responses and completion of the four induction ipilimumab doses. Conclusions: Ipilimumabin the Spanish EAP experience in pretreated patients has shown to improve long term survival similar to that seen in studies in patients with advanced melanoma. Further research and analysis are needed to identify the patient population most likely to achieve a long term survival benefit with ipilimumab treatment.